tourniquet modeling, analysis and physical testing
TRANSCRIPT
Blew Consulting, LLC
A report submitted to:
HALO Tactical Products, LLC 13728 Statesville Rd Huntersville, NC 28078 Attn: Daniel P. Cedrone Prepared by:
Douglas J. Blew, PE 135 Sienna Lane Mooresville, NC 28117 Phone: +1.828.244.0557 [email protected]
Testing Dates:
February 18 & 19, 2019
April 22, 2019
November 19, 2019
Final Report Date:
April 27, 2020
Disclaimer: This report was prepared by Blew Consulting, LLC for HALO Tactical Products, LLC. The material herein reflects Blew Consulting, LLC’s best judgment given
the information available at the time of preparation. Any use which a third party makes of this report, any reliance on or decision to be made based on it, are the
responsibility of such third parties. Blew Consulting, LLC accepts no responsibility for damages, if any, suffered by any third party as a result of decisions made or
actions based on this report.
Tourniquet Modeling, Analysis and Physical Testing
Abstract
This report joins and summarizes a series of prior reports where modeling,
analytical methods and physical testing were undertaken to validate
strength requirements and determine safety factors of a mechanical
battlefield applied tourniquet manufactured by HALO Tactical Products, LLC
(the Client).
In this document:
1. Executive Summary
2. Client Input / Testing Criteria
3. Modeling and Validation of Strength Criteria
4. Tourniquet Component Physical Testing
5. Complete Assembled Tourniquet Physical Testing
6. Appendix A - Detailed Test Data
7. Appendix B - Equipment List and Calibration
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1. Executive Summary
HALO Tactical Products, LLC contracted Blew Consulting, LLC to perform a series of mechanical strength tests on their
HALO® battlefield applied tourniquet and determine resultant margins of safety for critical individual components and
the tourniquet as a whole.
To calculate factors of safety (FoS) from strength values obtained from physical testing, minimum strength requirements
had to be either provided (known) or determined from criteria based on tourniquet application and use. As there were
no known strength values available, a study was undertaken to determine the maximum tensile strength the HALO®
tourniquet had to withstand based on established medical efficacy for inflatable surgical tourniquets. With the strength
requirement determined, all physical strength-testing results could then simply be divided by the required strength to
determine FoS.
HALO Tactical Products’ medical professional1 provided the following criteria to drive all simulation, analysis and testing:
- Maximum limb occlusion pressure (LOP) of 350 mmHg as referenced to a standard 3 inch wide inflatable surgical
tourniquet.
- 95th percentile adult male thigh size corresponding to a 28.13 inch circumference / 8.95 inch diameter.
Utilizing classical hoop-stress equations, computer finite element analysis and physical testing, it was determined that
an inflation pressure of 350 mmHg in a 3 inch wide surgical tourniquet resulted in a maximum cuff or circumferential
tension of 91 lbf. Utilizing the same calculation methods applied to the narrower width (1.71 inch) HALO® tourniquet
resulted in a circumferential tension of 52 lbf with the 350 mmHg simulated internal pressure. The reduction in
circumferential tension is a result of and directly proportional to the cuff area as determined by difference in width
between the two tourniquets.
Medical input and literature1, 2, 3, 4 indicates that narrower tourniquets actually require higher radial inward unit
pressures [pneumatically or mechanically generated] to occlude blood flow. As such, the maximum radial inward unit
pressure for the narrower (1.71 inch) HALO® tourniquet increases by an experimentally determined “Limb Occlusion
Formula3, 4” to a maximum of 536 mmHg to achieve the same efficacy as a 3.0 inch inflatable surgical tourniquet
operating at 350 mmHg. At this pressure, the resulting tension in the cuff of the 1.71 inch HALO® tourniquet is 80 lbf.
For both tourniquet component and complete tourniquet testing, sets of 5 articles each were tested at room
temperature, -20°F and +120°F. Based on the 80 lbf maximum tensile load occurring at the maximum tourniquet
applied pressure, the minimum average FoS for the individual components was 3.7.
When testing the entire tourniquet, as deployed around a simulated 95th percentile limb, the minimum average FoS was
4.5.
For a single use mechanical device, the Author recommends a minimum FoS of 1.5 (50% stronger than a worse-case
expected load) as appropriate.
1 Dr. William R, Carson, MD
2 J. A. McEwen, V. Casey. Measurement of hazardous pressure levels and gradients produced on human limbs by non-pneumatic tourniquets, (2009). CMBEC32.
Calgary, Canada; 2009 May 20-22. 3 Brent Graham, M.D., F.R.C.SC et al. Occlusion of Arterial Flow in the Extremities at Subsystolic Pressures Through the Use of Wide Tourniquet Cuffs. Clinical
Orthopaedics and Related Research; Number 286 - January 1983 4 COL John F. Kragh Jr., MCUSA et al. The Military Emergency Tourniquet Program’s Lessons Learned With Devices and Designs. Military Medicine, 176 10:1144, 2011
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2. Client Input / Testing Criteria
The Client requested the following:
1. An analysis to determine how inflation pressure applied to an inflatable medical surgical tourniquet correlates to
the resultant circumferential tensile forces within the cuff of a mechanically actuated tourniquet (or similar
device).
2. Physical tensile strength testing of various sub-components of Client’s tourniquet [HALO®] at room temperature,
-20°F and +120°F.
3. Physical tensile strength testing of the complete and fully deployed tourniquet at room temperature, -20°F and
+120°F.
For the correlation of inflation pressure to tensile force within the cuff, the Client provided a limit of 350 mmHg inflation
pressure as an upper testing limit for Limb Occlusion Pressure (LOP). LOP is the point where the applied pressure in a
tourniquet stops blood flow to a limb extremity beyond the applied tourniquet.
For the sub-component testing, the Client prepared individual samples attached to sewn loops sufficient to be
suspended between test-pin tooling of a tensile testing machine.
The Client stipulated and all analysis and testing of complete (whole) tourniquets were carried out on a simulated “limb”
sized for a 95th percentile adult male thigh (28.13 inch circumference). The corresponding diameter of 8.95” [diameter =
circumference / π] was used as input to calculations, computer simulations and the design fixturing for the physical
testing.
All tourniquets and other test specimens were supplied by the Client. All test fixtures and ancillary devices were
designed or provided by Blew Consulting, LLC. All physical testing took place at an independent lab by qualified testing
personnel.
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3. Modeling and Validation of Strength Criteria
When designing a part or an assembly (a series of joined parts), one must assure that there is no weak link in the
assembly which might fail in the course of normal use. It is further customary to overdesign components for
unanticipated situations, degradation or abuse by including a factor of safety (FoS) in the design criteria for strength,
fatigue, etc. There is no universal FoS, as safety levels are normally determined by type of industry and/or levels of
acceptable risk, but usually range from a low of 1.25 to a high of 4. Weight-critical designs utilized in aerospace typically
use a lower FoS, but compensate with extreme levels of quality control. The higher FoS criteria are employed for
applications such as pressure vessels and nuclear. Most building design utilizes a FoS between 1.75 and 2 for structural
members. In all cases, the design stress is determined, multiplied by the FoS and then the resulting value of stress is
used to ultimately design the component. If a design is already in existence, the FoS is determined by testing the design
for its strength and then dividing the strength of the components by the maximum design load / stress.
In the case of the subject mechanical tourniquet, there was no design stress level or tensile load requirement provided
by the Client – just the maximum LOP of 350 mmHg utilized in established inflatable surgical tourniquets. To determine
the required strength criteria for the mechanical tourniquet which corresponded to 350 mmHg of pressure applied to an
inflatable tourniquet, the Author chose to approach the problem via multiple methods:
First, fundamental and well-established design equations were applied to the problem.
Second, computer simulations were employed via Finite Element Analysis.
Last, actual physical lab tests were conducted utilizing an inflatable tourniquet.
All approaches are compared and then a “Limb Occlusion Formula3, 4” is used to apply the data obtained in the physical
testing of the inflatable tourniquet to the predicted results of the mechanical [HALO®] tourniquet.
CLASSICAL EQUATIONS
For thin-walled cylinders under a known uniform pressure [P], if the radius [r] and wall thickness [t] are known, the hoop
stress [ơh] can be determined by the formula:
ơh = P*r/t
The equation is a derivation of the Lame Equation for general hoop stress and is valid for cases where the diameter to
thickness ratio is greater than 20 (which is true in this case). Units can be in SI with Pressure denoted as Pascals and r
and t as meters or in Imperial units with Pressure in psi and r and t in inches.
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RESULTS
To determine the cross-sectional area of the strapping for the inflatable and mechanical tourniquets, the following
measured widths and assumed thicknesses were used:
Inflatable (actual width = 3.00”, thickness = 0.080”) Mechanical (actual width = 1.72”, thickness = 0.080”) For the thickness of the tourniquets, we can use an assumed thickness instead of exact values – as we are only
interested in the tensile forces generated and not the particular unit stress levels. For a given unit stress (psi), the area
(in the denominator) is simply canceled out when multiplied by the actual cross-sectional area to provide the tensile
force for a given strap width (it washes out). Thus, for a given stress level, the tensile force (lbf) in the strapping is
directly proportional to the width of the strap and has no relation to the strap thickness and the equation reduces to:
Force = ơh*Area The following table and graph show the results of the calculations (with all mmHg values converted to psi).
Pressure (mmHg)
Pressure (psi)
Stress (psi)
Inflatable Tensile (lbf)
HALO Tensile (lbf)
100 1.93 108.2 26.0 14.9
125 2.42 135.2 32.4 18.6
150 2.90 162.2 38.9 22.3
175 3.38 189.3 45.4 26.0
200 3.87 216.3 51.9 29.8
225 4.35 243.4 58.4 33.5
250 4.83 270.4 64.9 37.2
275 5.32 297.5 71.4 40.9
300 5.80 324.5 77.9 44.7
325 6.28 351.5 84.4 48.4
350 6.77 378.6 90.9 52.1
375 7.25 405.6 97.3 55.8
400 7.73 432.7 103.8 59.5
0.0
20.0
40.0
60.0
80.0
100.0
120.0
100 125 150 175 200 225 250 275 300 325 350 375 400
Ten
sile
fo
rce
(lb
f)
Pressure (mmHg)
Pressure -vs- Strapping Tensile Force
Inflatable Mechanical - HALO
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Finite Element Analysis Computer Simulations Computer simulation via Finite Element Analysis (FEA) can be used to accurately solve much more complex situations
than the simple reduced thin-wall Lame approximations. Models of the part(s) must be generated, material properties,
constraints and loads applied and then simulations can be executed.
METHOD
SolidWorks Professional 2018 was used to model 90-degree (1/4) segments of both the inflatable and mechanical
(HALO®) tourniquets. SolidWorks Simulation was then used to apply constraints to the models, apply internal pressure
and then solve for the resultant strains and loads. The setup dictates that only 90-degree bisected segments of the
whole model in the pure ‘X’ and pure ‘Y’ directions are required in order to capture the principle strains. The only
difference between the two models (inflatable vs mechanical – HALO®) was the width. Internal pressures were
simulated at 100 mmHg, 200 mmHg, 300 mmHg and 400 mmHg for each tourniquet type.
HALO® Model Inflatable Model
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RESULTS
Inflation Pressure (mmHg)
Tensile Force (lbf) Inflatable
Tensile Force (lbf) HALO®
100 25.9 14.9
200 51.8 29.7
300 77.8 44.6
350 (interpolated) 90.8 52.1
400 103.7 59.5
DISCUSSION / OBSERVATIONS / CONCLUSIONS
The 8 simulations solved in reasonable amount of time and generated results that highly agreed with the manual (Lame)
calculations.
0
20
40
60
80
100
120
100 200 300 400
Ten
sile
fo
rce
(lb
f)
Pressure (mmHg)
Pressure -vs- Strapping Tensile Force FEA Simulation Results
Inflatable Mechanical (HALO)
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Tourniquet Inflation Pressure -vs- Tensile Load Test It was theorized that test fixtures and components could be designed / fabricated / acquired such that tourniquet
inflation pressure could be readily correlated to the resultant tensile load imparted to the circumferential strap
surrounding the device by direct measurement.
METHOD
A fixture was constructed with the desired diameter (8.95”) and then separated into two halves (mandrels). The
mandrels were mounted into a tensile tester (Instron), positioned approximately 1/4” apart, an inflatable tourniquet
was applied around the exterior of the mandrels, the tourniquet was hooked up to a medical inflation device and then
deployed (inflated) in 25 mmHg increments from 100 mmHg to 400 mmHg. As the tourniquet was inflated, the resulting
tensile force between the two mandrel halves was measured. To check for any hysteresis effects, once the pressure
reached maximum (400 mmHg), the pressure was reduced back to 100 mmHg in 25 mmHg increments and also
recorded.
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RESULTS
Tabular and graphical results are shown below.
0
50
100
150
200
250
100 125 150 175 200 225 250 275 300 325 350 375 400
Ten
sile
fo
rce
(lb
f)
Pressure (mmHg)
Pressure -vs- Strapping Tensile Force
Series1 Series2 Series3 Series4
Inflation Pressure (mmHg)
Tensile Load (lbf) Up [Total]
Tensile Load (lbf) Down [Total]
Tensile Load (lbf) Avg [Total]
Tensile Load (lbf) [per leg]
100 45 45 45.0 22.5
125 59 60 59.5 29.8
150 69 70 69.5 34.8
175 83 82 82.5 41.3
200 96 93 94.5 47.3
225 106 106 106.0 53.0
250 119 118 118.5 59.3
275 130 130 130.0 65.0
300 143 141 142.0 71.0
325 155 154 154.5 77.3
350 169 165 167.0 83.5
375 178 175 176.5 88.3
400 191 186 188.5 94.3
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DISCUSSION / OBSERVATIONS / CONCLUSIONS
The force generated between the mandrels as a result of the inflation pressure behaved linearly. The values obtained
during inflation and deflation matched very well, indicating there was little hysteresis effect. The actual forces in the
tourniquet cuff are obtained by dividing the mandrel tensile force by 2. This is because there are two “legs” of the
tourniquet cuff that are resisting the forces exerted between the mandrels. This is illustrated by the following free-body
diagram that must be in balance:
Summary / Comparative Results
Inflation Pressure (mmHg)
Inflatable Calculated (lbf)
Inflatable FEA (lbf)
Inflatable Actual (lbf)
HALO® Calculated (lbf)
HALO® FEA (lbf)
100 26.0 25.9 22.5 14.9 14.9
125 32.4 29.8 18.6
150 38.9 34.8 22.3
175 45.4 41.3 26.0
200 51.9 51.8 47.3 29.8 29.7
225 58.4 53.0 33.5
250 64.9 59.3 37.2
275 71.4 65.0 40.9
300 77.9 77.8 71.0 44.7 44.6
325 84.4 77.3 48.4
350 90.9 90.8 83.5 52.1 52.1
375 97.3 88.3 55.8
400 103.8 103.7 94.3 59.5 59.5
0
20
40
60
80
100
120
100 125 150 175 200 225 250 275 300 325 350 375 400
Ten
sile
fo
rce
(lb
f)
Pressure (mmHg)
Modeling, Pressure -vs- Strapping Tensile Force
Cacl Inflatable FEA Inflatable Acutal Inflatable Calc HALO FEA HALO
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DISCUSSION / OBSERVATIONS / CONCLUSIONS
As previously noted, the manually calculated values (Lame) and finite element computer analyses highly agree with each
other for both tourniquet types. On average, for the inflatable tourniquet cases, there is a -10% difference between the
forces generated by actual inflation pressures in the physical tourniquet and the analytical results. This is a result of
non-linear forces across the width of the tourniquet and unavoidable inefficiencies as the inflatable bladder must work
against and overcome all of its constraining elements. Constraining elements for the bladder include the elastic forces
required to inflate the bladder, frictional forces between the bladder and the surrounding materials, and slight
pneumatic losses in the system.
The difference in strap (cuff) tensile force -vs- applied pressure between the inflatable tourniquet and the manually
applied tourniquet (HALO®) is entirely due to the difference in contact surface area between the two as determined by
the effective strap (cuff) widths. This is due to the application of pressure (stress) over differing areas…. [recalling earlier
that Force = stress * area].
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Correlation Between Inflatable and Mechanical Tourniquets
It has been previously shown that the resulting tensile force in an inflatable tourniquet strap (cuff) is not only
proportional to the inflation pressure, but also to the overall area that the pressure is applied over, as determined by
strap (cuff) width or strap area. In comparing tourniquets of different widths and differing mechanisms for generating
circumferential pressure [inflatable vs mechanical], medical research has been conducted that has resulted in the
following equation where LOP is determined as a function of the ratio of limb circumference to cuff width4,5.
LOP = (limb circumference / cuff width) 16.67 + 67
Substituting the cuff widths of the 3.0 inch inflatable surgical tourniquet and the 1.71 inch HALO® tourniquet in
combination with a 95th percentile limb circumference (28.13 inch), yields the following results:
Tourniquet Type Tourniquet Width (Inches)
Minimum Limb Occlusion Pressure (mmHg)
Inflatable Surgical 3.0 223
HALO® 1.71 341
At the minimum occlusion pressure, the effective pressure ratio between tourniquets is 1.53; thus the 1.71 inch
tourniquet requires 53% more pressure applied over its reduced area. For the maximum design pressure requirement of
350 mmHg for the normative inflatable tourniquet, the 1.71 inch HALO® tourniquet then correlates to 536 mmHg (1.53 *
350 mmHg).
From previously determined work, 536 mmHg acting over a 1.71 inch cuff can be linearly extracted to a cuff force (in
tension) of 79.7 lbf.
Based on the above, a maximum design tensile force of 80 lbf will be used in calculating factors of safety results
stemming from the physical testing of the actual tourniquets and tourniquet components.
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4. Tourniquet Component Physical Testing
INTRODUCTION
The Client requested tensile strength testing of specimens constructed from various isolated portions of the tourniquet
assembly. To facilitate testing, the Client prepared all samples with two sewn connection loops fashioned at the end of
each article. The loops were sufficient to slide over 5/8” mandrels attached to the test fixture which was in turn
attached to the tensile testing machine [Instron]. The temperatures requested were -20°F, 65°F – 75°F [room temp] and
+120°F. 5 samples were provided for testing at each temperature. The samples provided were not identifiable as to
model number, lot number or manufacturing date, but were all stated as being configurations representative of pre-
production samples.
METHOD
All samples were conditioned at their target temperature for a minimum of 2 hours. Room temperature samples were
simply left exposed within the lab room environment while the +120°F and -20°F samples were placed into calibrated
temperature-controlled chambers.
The 5/8” mandrels were pre-positioned at the approximate loop separation distance and the loops of the
subcomponents were slid around the mandrels. Each hot and cold sample was individually brought out of its controlled
environment, immediately wrapped in insulative material and then deployed on the test apparatus as quickly as possible
to preserve the article temperature. Once the article was in position, the tensile test was initiated at a rate of 2” /
minute and continued until the article under test failed. The maximum load [lbf] at failure and the failure mode was
recorded. All samples were returned to the Client after testing was completed.
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HALO® Main Strap Tensile Strength at 3 Different Temperatures
Tabular results are shown below. The individual stress-strain graphs are included in the appendix.
Test Sample Temp [°F] Result [lbf] Mode of Failure
1 Room 301.8 Failed at outer edge of single-stitched loop
2 Room 292.5 Failed at inner edge of double-stitched loop
3 Room 285.0 Failed at inner edge of single-stitched loop
4 Room 305.7 Failed at inner edge of double-stitched loop
5 Room 310.0 Failed at inner edge of double-stitched loop
Average 299.0
Std Dev 10.1
Test Sample Temp [°F] Result [lbf] Mode of Failure
1 -20 302.9 Failed at inner edge of single-stitched loop
2 -20 299.6 Failed at inner edge of single-stitched loop
3 -20 324.4 Failed at inner edge of single-stitched loop
4 -20 324.2 Failed ~ 50% at both edges of stitched loop
5 -20 330.8 Failed at inner edge of single-stitched loop
Average 316.4
Std Dev 14.1
Test Sample Temp [°F] Result [lbf] Mode of Failure
1 +120 275.1 Failed at inner edge of single-stitched loop
2 +120 260.1 Failed at inner edge of single-stitched loop
3 +120 320.7 Failed at inner edge of single-stitched loop
4 +120 327.5 Failed at inner edge of single-stitched loop
5 +120 298.2 Failed at inner edge of double-stitched loop
Average 296.3
Std Dev 28.9
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DISCUSSION / OBSERVATIONS / CONCLUSIONS
All the specimens failed in pure tensile at one edge or the other of the sewn area where the loops are joined back into
the main strapping material. All but one sample failed at the inner edge of the sewn strap (facing towards the center of
the test sample). 4 of 15 samples failed at the double stitched interface; however it should be noted that this loop was
consistently formed such that the active “hook” material was adjoining each other at the sewn interface. Conversely, all
the single sewn interfaces had the smoother “loop” sides contacting each other and exhibited no latching effect at the
overlapping sewn interface. The points of failure indicate that the punctures in the material due to stitching reduce the
effective strap area and/or create stress concentration areas that bias the failures to those areas.
The average of all results had 20.1 lbf variation between them, with the +120°F sample set having the most significant
variation when standard deviations were taken into account.
At the maximum tensile force of 80 lbf, the resulting testing indicates a minimum FoS of 3.7 occurring at +120°F.
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HALO® Locking Strap Tensile Strength at 3 Different Temperatures
RESULTS
Tabular results are shown below. The individual stress-strain graphs are included in the appendix.
Test Sample Temp [°F] Result [lbf] Mode of Failure
1 Room 225.3 Failed between loop stitching and buckle stitching
2 Room 236.7 Same as above
3 Room 226.7 Same as above
4 Room 212.2 Same as above
5 Room 235.0 Same as above
Average 227.2
Std Dev 9.7
Test Sample Temp [°F] Result [lbf] Mode of Failure
1 -20 230.4 Failed between loop stitching and buckle stitching
2 -20 230.4 Same as above
3 -20 217.5 Same as above
4 -20 229.2 Same as above
5 -20 222.3 Same as above
Average 226.0
Std Dev 5.8
Test Sample Temp [°F] Result [lbf] Mode of Failure
1 +120 218.4 Failed between loop stitching and buckle stitching
2 +120 232.3 Same as above
3 +120 236.9 Same as above
4 +120 232.0 Same as above
5 +120 227.7 Same as above
Average 229.5
Std Dev 7.0
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DISCUSSION / OBSERVATIONS / CONCLUSIONS
All the specimens failed in pure tensile within the single width of material between the two stitched loops. More
specifically, the failures were all immediately adjacent to one or the other of the stitched areas. The points of failure
indicate that the punctures in the material due to stitching reduce the effective strap area and/or create stress
concentration areas that bias the failures to those areas.
Comparing the averages between temperature groups yields only 3.5 lbf variation with standard deviations all below 10
lbf. Unlike the main strap, this locking strap is responsible for actuating and securing the lever action of the buckle and
is mechanically subjected to less tensile stress than the main strap during deployment. Based on measurements of the
buckle, the mechanical advantage provided by the geometry is approximately 3.3x. With a main strap maximum tensile
force of 80 lbf, the force required to achieve this from the locking strap would be reduced by a factor of 3.3 to 24.2 lbf,
resulting in a minimum average FoS of 9.3 occurring at -20°F for the locking strap material. It must be kept in mind,
however, that the actual retention of the strap in a stationary position after deployment relies on a “hook and loop”
material attachment to hold the buckle in a deployed position. This is evaluated in the following section when testing
the entire tourniquet.
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HALO® Locking Buckle with Main Strap Material Tensile Strength at 3 Different Temperatures
RESULTS
Tabular results are shown below. The individual stress-strain graphs are included in the appendix.
Test Sample Temp [°F] Result [lbf] Mode of Failure
1 Room 256.5 Failed between loop stitching and buckle stitching
2 Room 331.2 Same as above
3 Room 309.6 Same as above
4 Room 276.9 Same as above
5 Room 322.0 Same as above
Average 299.2
Std Dev 31.5
Test Sample Temp [°F] Result [lbf] Mode of Failure
1 -20 314.4 Failed between loop stitching and buckle stitching
2 -20 314.1 Same as above
3 -20 333.8 Same as above
4 -20 291.1 Same as above
5 -20 334.1 Same as above
Average 317.5
Std Dev 17.7
Test Sample Temp [°F] Result [lbf] Mode of Failure
1 +120 274.9 Failed between loop stitching and buckle stitching
2 +120 333.6 Same as above
3 +120 261.8 Same as above
4 +120 329.8 Same as above
5 +120 355.4 Same as above
Average 311.1
Std Dev 40.5
P a g e | 19
DISCUSSION / OBSERVATIONS / CONCLUSIONS
All the specimens failed in pure tensile within the single width of material between the two stitched loops. More
specifically, the failures were all immediately adjacent to one or the other stitched areas. The points of failure indicate
that the punctures in the material due to stitching reduce the effective strap area and/or create stress concentration
areas that bias the failures to those areas.
Comparing the averages between temperature groups yields 18.3 lbf variation with standard deviations ranging from
17.7 to 40.5. The main strap construction has “hook” material on one side and “loop” material on the opposite side. In
the formation of the loops, the “loop” sides formed the inside of the test loop and as such were sewn facing each other.
It has been observed in testing that adjoining “hook-loop” and “hook-hook” surfaces results in adhesion, while this is not
true for the “loop-loop” orientation represented in these articles under test. Based on observed test behavior, the
author believes the alternate orientations may slightly improve the resulting tensile strength of the joint.
At the maximum tensile force of 80 lbf, the resulting testing indicates a minimum FoS of 3.7 occurring at 68°F.
P a g e | 20
5. Complete Assembled Tourniquet Physical Testing
INTRODUCTION
The Client requested tensile strength testing of a deployed HALO® tourniquet applied around a mandrel sized for a 95th
percentile adult male thigh (28.13 inch circumference - further provided by the Client). The corresponding diameter of
8.95” [diameter = circumference / π] was used to design fixturing for the tensile test. Two identical mandrel halves were
designed and fabricated to hold the tourniquet and to interface with the tensile testing machine [Instron]. The
temperatures requested were -20°F, 65°F – 75°F [room temp] and +120°F. 5 samples were provided for testing at each
temperature. The samples provided were not identifiable as to model number, lot number or manufacturing date, but
were stated as being pre-production samples.
METHOD
All samples were conditioned at their target temperature for a minimum of 2 hours. Room temperature samples were
simply left exposed within the lab room environment while the +120°F and -20°F samples were placed into calibrated
temperature-controlled chambers.
The mandrel halves were positioned approximately ¼” apart, the tourniquets were wrapped around the exterior of the
mandrels and then deployed (tightened) according to the manufacturer’s instructions. The additional “hook and loop”
“finger loop locking tab” strap was evenly positioned such that it additionally secured the distal end of the main strap
where it is affixed back onto itself as shown below.
Hot and cold samples were individually brought out of their controlled environments, immediately wrapped in insulative
material and then deployed on the test apparatus as quickly as possible to preserve the article temperature. Once
deployed, the tensile test was initiated at a rate of 2” / minute and continued until the article under test failed due to
either breakage or slippage of the securing straps. The maximum load [lbf] at failure and the failure mode were
recorded. All samples were returned to the Client after testing was completed.
P a g e | 21
RESULTS
Test Sample Temp [°F] Result [lbf] Mode of Failure
1 Room 768.3 Release of “hook and loop” main strap in shear
2 Room 671.1 Main strap broke at sewn buckle end
3* Room 395.8* Test error, test repeated with new sample
4 Room 734.0 Release of “hook and loop” main strap in shear
5 Room 763.2 Main strap broke mid-span
6* Room 717.8 Additional sample tested, strap broke at buckle end
Average 730.9* *Sample 3 eliminated from data
Std Dev 39.4* *Sample 3 eliminated from data
Test Sample Temp [°F] Result [lbf] Mode of Failure
1 +120 832.0 Main strap broke mid-span
2 +120 623.1 Release of “hook and loop” main strap in shear
3 +120 716.8 Release of “hook and loop” main strap in shear
4 +120 723.8 Release of “hook and loop” main strap in shear
5 +120 740.9 Release of “hook and loop” main strap in shear
Average 727.3
Std Dev 74.4
Test Sample Temp [°F] Result [lbf] Mode of Failure
1 -20 741.9 Main strap broke mid-span
2 -20 776.2 Main strap broke mid-span
3 -20 707.0 Release of “hook and loop” main strap in shear
4 -20 787.9 Main strap broke mid-span
5 -20 759.3 Main strap broke mid-span
Average 754.5
Std Dev 31.7
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DISCUSSION / OBSERVATIONS / CONCLUSIONS
The actual forces in the strapping are obtained by dividing the mandrel pulling tensile force by 2. This is because there
are two “legs” of the tourniquet that are resisting the forces exerted between the mandrels. This is illustrated by the
following free-body diagram:
The tourniquets failed in 3 different modes, with an overall range of 623 lbf – 832 lbf. In 7 of the tests, the “hook and
loop” interface of the main strap (with the “finger loop locking tab” attached) released gradually via shear. In 6 of the
tests, the main strap broke in tensile near the middle of the tourniquet. The remaining 2 failures were at the stitching
where the main strap is sewn back onto itself after wrapping around the buckle.
The results at +120°F showed more variation than the other sample groups with the highest load [832.0 lbf] and lowest
load [623.1 lbf] and a corresponding standard deviation of 39.4 lbf. The -20°F group had the highest average [754.5 lbf]
and also the narrowest standard deviation of 31.7 lbf. The Author surmises that the yield strengths of the interlocked
plastic “hooks” and “loops” decrease with increasing temperature and result in an earlier release at the elevated
condition.
At the maximum tensile force of 80 lbf, the resulting testing indicates a minimum FoS of 4.5 occurring at +120°F.
P a g e | 23
6. Appendix A - Detailed Test Data
0
50
100
150
200
250
300
350
0.00 0.20 0.40 0.60 0.80 1.00 1.20 1.40 1.60
Load
(lb
f)
Extension (in)
HALO® Main Strap Tensile Strength - Room Temp
Sample 1
Sample 2
Sample 3
Sample 4
Sample 5
0
50
100
150
200
250
300
350
0.00 0.20 0.40 0.60 0.80 1.00 1.20 1.40 1.60
Load
(lb
f)
Extension (in)
HALO® Main Strap Tensile Strength -20°F
Sample 1
Sample 2
Sample 3
Sample 4
Sample 5
0
50
100
150
200
250
300
350
0.00 0.20 0.40 0.60 0.80 1.00 1.20 1.40 1.60 1.80
Load
(lb
f)
Extension (in)
HALO® Main Strap Tensile Strength +120°F
Sample 1
Sample 2
Sample 3
Sample 4
Sample 5
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0
50
100
150
200
250
0.00 0.20 0.40 0.60 0.80 1.00 1.20 1.40 1.60 1.80 2.00
Load
(lb
f)
Extension (in)
HALO® Locking Strap Tensile Strength - Room Temp
Sample 1
Sample 2
Sample 3
Sample 4
Sample 5
0
50
100
150
200
250
0.00 0.20 0.40 0.60 0.80 1.00 1.20 1.40 1.60 1.80
Load
(lb
f)
Extension (in)
HALO® Locking Strap Tensile Strength - 20°F
Sample 1
Sample 2
Sample 3
Sample 4
Sample 5
0
50
100
150
200
250
0.00 0.20 0.40 0.60 0.80 1.00 1.20 1.40 1.60 1.80
Load
(lb
f)
Extension (in)
HALO® Locking Strap Tensile Strength + 120°F
Sample 1
Sample 2
Sample 3
Sample 4
Sample 5
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0
50
100
150
200
250
300
350
0.00 0.50 1.00 1.50 2.00 2.50
Load
(lb
f)
Extension (in)
HALO® Locking Buckle w/ Main Strap Material Tensile Strength - Room Temp
Sample 1
Sample 2
Sample 3
Sample 4
Sample 5
0
50
100
150
200
250
300
350
400
0.00 0.50 1.00 1.50 2.00 2.50
Load
(lb
f)
Extension (in)
HALO® Locking Buckle w/ Main Strap Material Tensile Strength - 20°F
Sample 1
Sample 2
Sample 3
Sample 4
Sample 5
0
50
100
150
200
250
300
350
400
0.00 0.50 1.00 1.50 2.00 2.50
Load
(lb
f)
Extension (in)
HALO® Locking Buckle w/ Main Strap Material Tensile Strength + 120°F
Sample 1
Sample 2
Sample 3
Sample 4
Sample 5
P a g e | 26
0.0
100.0
200.0
300.0
400.0
500.0
600.0
700.0
800.0
900.0
0.00 0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00
Load
(lb
f)
Extension (in)
HALO® Complete, Loop Tensile - Room Temp
Sample 1
Sample 2
Sample 4
Sample 5
Sample 6
0.0
100.0
200.0
300.0
400.0
500.0
600.0
700.0
800.0
900.0
0.00 0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50
Load
(lb
f)
Extension (in)
HALO® Complete, Loop Tensile +120°F
Sample 1
Sample 2
Sample 3
Sample 4
Sample 5
0.0
100.0
200.0
300.0
400.0
500.0
600.0
700.0
800.0
900.0
0.00 0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00
Load
(lb
f)
Extension (in)
HALO® Complete, Loop Tensile -20°F
Sample 1
Sample 2
Sample 3
Sample 4
Sample 5
P a g e | 27
7. Appendix B - Equipment List and Calibration
1. Instron Tensile Tester
Model #: 5567
Serial #: 5567-C5428
Load Cell: 2525-810, Serial #: 132
2. Stryker Color Cuff®
Size: 34 in
Model #: 5921-034-701
3. SCANDMED Tourniquet Inflation System
Model #: 400-40
Serial #: 8120
Serviced: 8/2018
Due: 9/2020
4. Cincinnati Sub-Zero Environmental Chamber
Model #: ZP-32-3.5-SCT/AC
Serial #: ZP0711198
5. Fisher Scientific Recirculating Oven
Model #: 725F
Serial #: 1584061011161
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